Effects of clean intermittent self-catheterization on late bladder dysfunction after radical hysterectomy in cervical cancer.

OBJECTIVE: To identify the benefits of clean intermittent self-catheterization in women who have late bladder dysfunction caused by radical hysterectomy in cervical cancer.
METHODS: Thirty women who underwent radical hysterectomy with late bladder dysfunction were recruited. A nursing intervention program focusing on clean intermittent self-catheterization and a drinking plan was implemented. We recorded urinary times during the day and night, post-voiding residual urine volume, positive catheter specimen of urine rate, and quality of life instruments for patients with cervical cancer .
RESULTS: All patients were able to satisfactorily manage clean intermittent self-catheterization following video-based operational training. Bladder function was significantly increased after 3-month intervention compared with before the intervention. Urinary times during the day and night, and post-voiding residual urine volume were greatly decreased post-intervention compared with pre-intervention. The rate of a positive catheter specimen of urine test significantly decreased over time. There was significant improvement in quality of life in five dimensions between weeks 1 and 12 following the intervention.
CONCLUSIONS: Patients are able to learn the technique of clean intermittent self-catheterization without any difficulty. This technique is effective together with a drinking plan to decrease late bladder dysfunction caused by radical hysterectomy in cervical cancer.

Introduction

Despite effective prevention, cervical cancer (CC) is still a major cancer in women. Radical hysterectomy (RH) with pelvic lymphadenectomy is regarded as the standard surgical treatment for Federation of Gynecology and Obstetrics stages IB1–IIA CC. Generally, the 5-year overall survival rate for patients with CC is approximately 65%, and that early-stage CC ranges from 88% to 97%.[1-3] Additionally, more than 50% of patients with CC are younger than 50 years. Therefore, a radical surgical procedure should achieve the best possible oncological outcome, while diminishing short- and long-term complications. However, bladder dysfunction, caused by pelvic parasympathetic nerve impairment after RH, is the most common long-term complication of RH (8%–80%), with an average rate of 72%.[4-7] Bladder dysfunction may affect the patient’s quality of life.[8,9] Some patients with CC suffer from late bladder dysfunction, resulting in voiding dysfunction, such as urinary retention, which has a pronounced effect on quality of life.[10,11]

Clean intermittent self-catheterization (CISC) has been successfully introduced in many different areas of healthcare, including urological and gynecological surgical practice. In particular, these benefits appear to be useful in children, adolescents, older people, and the neurologically impaired.[12-14]

In this study, we investigated whether the proven benefits of CISC in early bladder care of women following RH are appropriate in late postoperative bladder dysfunction care in Chinese women.[15-17]

Materials and methods

All women who were included in the study were considered as having bladder dysfunction at 6 to 12 months after RH between 7 April 2015 and 15 March 2016 at Zhejiang Cancer Hospital, Hangzhou, China. We excluded patients who were survivors with adjuvant radiotherapy after RH and those with vesicovaginal fistula or previous bladder issues. Additionally, uncooperative patients and/or those with mental impairment were not included. Ethical approval for the study was obtained from Zhejiang Cancer Hospital Medical Ethics Committee.

Longitudinal section analysis was performed in 30 survivors with CC who were considered suitable for recruitment into the study. Following informed consent, patients were instructed in the use of CISC. Pre-interventional data included patients’ demographics (Table 1), urinary times during the day and night, post-voiding residual urine volume (PVRUV), and the ability to manage CISC following video-based operational training. Post-interventional data were collected during 12 weeks following CISC. The data included compliance to the CISC protocol, a catheter specimen of urine (CSU) for culture and sensitivity at days 1, 3, 7, 14, and 21, unexpected events including problems/difficulties with bladder management, and quality of life instruments for patients with cervical cancer (QLICP-CE) questionnaires at week 1 and week 12. All questionnaires were sent as electronic versions by investigators and completed by patients at home, and then returned by e-mail. All analyses were performed on an intention-to-treat basis.

Table 1.

General characteristics of the women.

Variables	Categories	n (%)
Age (years)	30–39	6 (20)
	40–49	15 (50)
	50–59	9 (30)
Religion	Yes	3 (10)
	No	27 (90)
Education level	Primary school diploma	1 (3)
	Middle school diploma	8 (27)
	High school diploma	12 (40)
	Bachelor or above	9 (30)
Marital status	Not married	0 (0)
	Married	29 (97)
	Widowed	0 (0)
	Divorced	1 (3)
Number of family members	1	0 (0)
	2	1 (3)
	≥3	29 (97)
Surgical approach	Translaparoscopic	18 (60)
	Transabdominal	12 (40)
Stage	IB1	30 (100)
Pathological type	Squamous cell carcinoma	30 (100)

All studied women started learning CISC by an operational video and actual demonstration by a doctor from the first day when they visited doctors at Zhejiang Cancer Hospital. The women commenced CISC with a drinking plan (Table 2) as the interventional measure after they were able to manage CISC satisfactorily. This interventional measure was continued for 3 months. A hydrophilic-coated catheter was used for CISC (EasiCath product version: 5374; Coloplast Ltd., Humlebæk, Denmark). Prophylactic antibiotics were not provided to any patients at any other time during the study. However, antibiotics were prescribed when clinically indicated (i.e., a positive CSU culture).

Table 2.

Drinking plan during 24 hours.

Time (hours)	Water intake (mL)
7:00–8:00	400
9:00–10:00	200
11:00–12:00	400
14:00–15:00	200
16:00–17:00	400
18:00–19:00	200

The total quantity of water included water from food. There was drinking after 20:00 to 06:00 hours during the night.

Pearson’s chi-squared test was used to analyze categorical data and Fisher’s exact test was used for numerical data. Statistical significance was indicated by P < 0.05. All statistical tests were performed using SPSS Version 17.0 (SPSS Inc., Chicago, IL, USA).

Results

Thirty women were recruited into the study. The median age of the patients was 45 years (range: 35–54 years). All women had stage IB1 CC and were treated by type III RH. All patients were considered to satisfactorily perform CISC following a period of pre-interventional training. Urinary times during the day and night were significantly decreased post-intervention compared with pre-intervention (both P < 0.001) (Table 3). Post-intervention PVRUV was significantly decreased compared with pre-intervention (P < 0.001) (Table 3).

Table 3.

Urinary times during the day and night, and PVRUV.

	Pre-intervention	Post-intervention.	P
	x¯ ± s	x¯ ± s
Urinary times in the day	17.2 ± 3.65	7.2 ± 1.93	<0.001
Urinary times in the night	7.35 ± 2.32	2.41±1.12	<0.001
PVRUV (mL)	248.78 ± 103.94	106.12 ± 30.31	<0.001

Values are mean ± standard deviation. PVRUV: post-void residual urine volume.

We found that 12 of 30 (40%) patients had a positive CSU test on days 1 and 3, and they were treated with sensitive antibiotics. Fifteen (50%) patients had a positive CSU on day 7. However, this rate of a positive CSU test had decreased by day 21. There was a significant difference in the rate of a positive CSU test over time (P = 0.005) (Table 4).

Table 4.

Positive CSU rate.

	Day 1	Day 3	Day 7	Day 14	Day 21
	n (%)	n (%)	n (%)	n (%)	n (%)	χ2	P
Positive CSU rate	12 (40)	12 (40)	15 (50)	9 (30)	3 (10)	12.605	0.005

CSU: catheter specimen of urine.

All patients completed and returned the QLICP-CE questionnaires. We found that there was a significant improvement in quality of life in five dimensions between weeks 1 and 12 following the intervention (all P < 0.01, Table 5).

Table 5.

QLICP-CE questionnaire (week 1 vs. week 12).

	Week 1	Week 12
Dimensions	x¯ ± s (mean ± SD)	x¯ ± s (mean ± SD)	t	P
Physical function	23.41 ± 15.58	65.48 ± 5.92	9.727	<0.001
Psychological function	19.44 ± 11.31	60.88 ± 7.27	14.641	<0.001
Social function	36.11 ± 14.88	57.41 ± 15.97	4.763	.001
Common symptoms and side effects	64.68 ± 16.79	91.27 ± 5.95	4.930	.001
Specific module	29.52 ± 11.91	62.85 ± 8.04	7.024	<0.001
Total score	32.57 ± 11.90	66.88 ± 5.68	11.944	<0.001

QLICP-CE: quality of life instruments for patients with cervical cancer; SD: standard deviation.

There tended to be improvement in women’s attitude towards bladder management between week 1 and week 12 (P = 0.06) (Table 6). CISC did not appear to be effective regarding sexual attitude in these women (Table 6).

Table 6.

Attitude of patients regarding bladder management and sexual function (week 1 vs. week 12).

Attitude status		Positive	Unsure	Negative	P
Towards bladder management, n (%)	Week 1	9 (30)	15 (50)	6 (20)	0.06
	Week 12	18 (62)	8 (27.5)	4 (10.5)
Towards sexual function, n (%)	Week 1	0 (0)	0 (0)	30 (100)	0.492
	Week 12	0 (0)	2 (7)	28 (93)

Discussion

To the best of our knowledge, the current study is one of only a few studies of CISC for bladder care following RH for CC with late postoperative bladder dysfunction in China.[18] In the present study, all patients were able to learn the technique of CISC without difficulty and were followed by a clinical nurse specialist in the hospital. We found significant benefits of CISC, including great acceptability for women with late postoperative bladder dysfunction, particularly bladder compliance and voiding function. We found that there were fewer urinary disturbances during the day and night post-intervention, which led to greater freedom and normal life. Quality of life was greatly increased after the 3-month intervention. However, high urinary tract infection rates on days 1, 3, and 7 were concerning, although there was a significant difference in the incidence of a positive CSU test. This finding is similar to a study by Naik et al.[15] In our study, CISC did not contribute to increase the incidence of urinary tract infection. However, the most frequent complication of intermittent catheterization is urinary tract infection.[19,20] There were no significant benefits for improving the attitude of patients towards bladder management and sexual functional recovery among the women in our study. The reasons for this lack of finding might be related to Chinese culture background, general medical and sexual cognition of women, and the level of sensitivity of sexual healthcare in clinical nurses.[21-24]

In conclusion, bladder dysfunction is the most common complication in postoperative patients with CC. Patients are able to learn the technique of CISC without difficulty. CISC is effective together with a drinking plan to decrease late bladder dysfunction caused by RH in CC. Nurses need to deliver these effective measures. However, more related, well-designed, prospective studies are strongly recommended. Furthermore, because sexual health is a vital component of quality of life and overall health in oncology patients,[13] more related trials are also recommended.